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Differences between unselected patients and participants in multiple myeloma clinical trials in US: a threat to external validity. Leuk Lymphoma 2016 12;57(12):2827-2832 PMID: 27104965

Pubmed ID

27104965

Abstract

External validity of clinical trials is affected by dissimilarities between study subjects and patient population. We identified 128 manuscripts (8,869 subjects) published between 2007 and 2014 reporting results of multiple myeloma (MM) trials performed entirely in the US. Characteristics of subjects were compared with unselected patients from SEER-18. Median of median age of subjects was 61 years vs. median age of unselected patients of 69 years. Trial subjects with untreated MM had less advanced stage than unselected patients. Racial-ethnic composition was informed in only 51 (39.8%) trials. Industry-sponsored trials were more likely to report accrual of minorities than National Cancer Institute (NCI) or investigator-sponsored trials. The observed/expected minority accrual was 0.52 (95% CI 0.49-0.55), being lower (0.43) in investigator-sponsored and higher (0.61) in industry-sponsored trials. We concluded that minorities, older individuals and persons with more advanced disease are underrepresented in MM trials, potentially compromising external validity of results.

Author List

Costa LJ, Hari PN, Kumar SK

Author

Parameswaran Hari MD Chief, Professor in the Medicine department at Medical College of Wisconsin




Scopus

2-s2.0-84964492889   12 Citations

MESH terms used to index this publication - Major topics in bold

Adult
Age Factors
Aged
Aged, 80 and over
Clinical Trials as Topic
Ethnic Groups
Female
Humans
Male
Middle Aged
Multiple Myeloma
Patient Selection
Reproducibility of Results
SEER Program
Sex Factors
United States
jenkins-FCD Prod-332 f92a19b0ec5e8e1eff783fac390ec127e367c2b5